Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis (TERIKIDS)
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|ClinicalTrials.gov Identifier: NCT02201108|
Recruitment Status : Active, not recruiting
First Posted : July 25, 2014
Last Update Posted : October 30, 2018
To assess the effect of teriflunomide in comparison to placebo on disease activity measured by time to first clinical relapse after randomization in children and adolescents 10 to 17 years of age with relapsing forms of multiple sclerosis.
- To assess the effect of teriflunomide in comparison to placebo on disease activity/progression measured by brain magnetic resonance imaging (MRI) and on cognitive function.
- To evaluate the safety and tolerability of teriflunomide in comparison to placebo.
- To evaluate the pharmacokinetics (PK) of teriflunomide.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Teriflunomide Drug: Placebo||Phase 3|
The study duration includes a screening period up to 4 weeks, a double-blind treatment period of up to 96 weeks, an open-label period including the remainder of the initial 96 weeks, where applicable, and a 96-week extension, i.e., up to a maximum of 192 weeks after randomization. There will be a follow-up period of 4 weeks for participants discontinuing treatment.
Within the 96 weeks double-blind treatment period, the first 4 weeks are pharmacokinetic (PK) run-in phase in which PK samples (blood samples) will be collected from participants and then 4 weeks of analysis (no samples drawn). The PK run-in phase (total 8 weeks) is intended to provide individual PK parameters to allow the dose adjustment to the 14 mg adult-equivalent dose for the rest of the study.
Participants experiencing a relapse after the PK run-in phase (8 weeks) and if confirmed by the Relapse Adjudication Panel (RAP) and patients fulfilling MRI criteria (high number of new lesions at week 36, 48 or 72 compared to previous images) will have the option to continue in an open label teriflunomide treatment arm up to 192 weeks from randomization.
An optional additional extension period is available for young participants with teriflunomide until the participants are 18 years old and/or able to switch to commercial product, whichever comes first.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||165 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients With Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension|
|Study Start Date :||July 16, 2014|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||September 2021|
Placebo Comparator: Placebo
Matching placebo tablets
Pharmaceutical form:tablet Route of administration: oral
Teriflunomide oral tablet, three dosages (3.5, 7 or 14 mg) to reach 14 mg adult equivalent
Pharmaceutical form:film-coated tablet Route of administration: oral
Other Name: AUBAGIO, HMR1726
- Time to first clinical relapse after randomization [ Time Frame: over 96 weeks ]
- Proportion of relapse free participants [ Time Frame: at 24, 48, 72 and 96 weeks ]
- Number of of new/newly enlarged T2 lesions [ Time Frame: over 96 weeks ]
- Number of T1 Gd-enhancing T1 lesions [ Time Frame: over 96 weeks ]
- Change in volume of T2 lesions [ Time Frame: over 96 weeks ]
- Change in volume of T1 hypointense lesions [ Time Frame: over 96 weeks ]
- Number of new T1 hypointense lesions [ Time Frame: over 96 weeks ]
- Proportion of participants free of new or enlarged MRI T2-lesions [ Time Frame: at 48 weeks and 96 weeks ]
- Brain atrophy [ Time Frame: over 96 weeks ]
- Change in performance on symbol digit modalities test (SDMT) and Cognitive Battery Test [ Time Frame: at randomization, then every 24 weeks (SDMT only) and at 96 weeks ]
- Safety, as assessed by clinical, laboratory, ECG, and vital signs events [ Time Frame: over 96 weeks ]
- Assessment of teriflunomide pharmacokinetics (PK) parameter: (Ctrough) lowest concentration of drug in the blood measured after dosing [ Time Frame: at Weeks 2, 3, 4, 8, 12, 24, 36 and 96 ]
- Assessment of teriflunomide PK parameter: (Cmax) maximum plasma drug concentration [ Time Frame: at Weeks 2, 3, 4, 8, 12, 24, 36 and 96 ]
- Assessment of teriflunomide PK parameter: (AUC0-24) area under the plasma concentration-time curve from time zero to 24 hours [ Time Frame: at Weeks 2, 3, 4, 8, 12, 24, 36 and 96 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02201108
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|Study Director:||Clinical Sciences & Operations||Sanofi|